A few months ago, the Irish drug company Allergan moved to shield its key patents on its dry-eye drug Restasis from challenge at the Patent Trial and Appeal Board (PTAB) of the U.S. Patent Office by assigning these patents to the Saint Regis Mohawk Tribe in return for a commitment by the tribe, as new owner of the patents, to invoke “sovereign immunity” and request that the PTAB dismiss pending administrative challenges.

However, a recent decision in an unrelated case before the PTAB casts doubt on the viability of this strategy.  In Ericsson v. Regents of the University of Minnesota, IPR2017-01186 (Paper 16 PTAB Dec. 19, 2017), an expanded panel of seven PTAB judges denied the University of Minnesota’s motion to dismiss an inter partes review (IPR) proceeding on the basis of sovereign immunity.  According to the PTAB panel, by filing a patent infringement suit that asserted the challenged patent, the University had waived its immunity at least with respect to the defendants.  One of defendants in that suit, Ericsson, Inc., had initiated the IPR proceeding.

The Ericsson decision involved the questionable practice of “panel-packing” by the PTAB’s chief judge, David Ruschke.  In this instance, the Chief Judge added himself and three of his deputies to the original three judges assigned to the case for the purpose of deciding the University’s motion to dismiss, ostensibly to address the “exceptional nature of the issues presented.”

Two prior PTAB decisions by different panels of judges involving University-owned patents have upheld the sovereign immunity principle.  In Covidien LP v. Univ. of Fla. Research Found., Inc., Case IPR2016-01274 (PTAB Jan. 25, 2017) and NeoChord, Inc. v. Univ. of Md., Balt., Case IPR2016-00208 (PTAB May 23, 2017), prior panels of PTAB judges faced with this issue had found that an IPR proceeding was an adjudicatory proceeding of a federal agency from which state entities are immune.

Judge Ruschke’s opinion on behalf of the enlarged panel confirmed that the sovereign immunity defense was generally available to state universities (and, by implication, other sovereigns like native American tribes) but the immunity was not absolute.  By suing in federal court, Ruschke reasoned that University of Minnesota had waivered this immunity.  He distinguished the prior PTAB panel decisions dismissing IPR petitions on sovereign immunity grounds because they did not involve “a State that filed an action in federal court alleging infringement of the same patent.”  (The Covidien v. Florida case arose out of a licensing dispute in which the university had sued to enforce a patent license agreement and the disgruntled licensee then challenged the patent via an IPR petition.  The Neochord v. Maryland case likewise involved a licensing dispute.)

Nonetheless, Judge Ruschke’s opinion has a logical weakness.  The panel’s finding of a waiver appears to turn on the fact that an invalidity challenge to a patent in a federal infringement case is a compulsory counterclaim.  Because the invalidity challenge must be brought or “be forever barred from doing so, it is not unreasonable to view the state as having consented to such counterclaims.”  The opinion fails to explain why the counterclaim inherent in an infringement suit (i.e. a trial of the invalidity issue in the federal court) is not sufficient in and of itself or why the compulsory nature of the counterclaim should spawn a right to raise this issue in an alternative forum with significantly different (challenger-friendly) rules. 
Continue Reading Allergan’s Mohawk Gambit May Be Doomed – PTAB Rethinks the Scope of Sovereign Immunity

An en banc panel of the Court of Appeals for the Federal Circuit (CAFC) in the case of Aqua Products, Inc. v. Matal recently held that in an inter-partes (IPR) proceeding, the burden of persuasion rests with the challenger to persuade the PATB that substitute claims proposed by a patent owner in a motion to

The Federal Circuit Court of Appeals again vacated a Patent Trial and Appeal Board (PTAB) panel decision for failing to properly evaluate “objective evidence of non-obviousness” and remanded the case for determinations consistent with its opinion. Specifically, the Fed. Cir. panel faulted the PTAB’s analysis Patent Owner’s objective evidence of unexpected results and further found

In an inter partes review (IPR) proceeding, the meaning of terms used in challenged claims of an unexpired patent are given their broadest reasonable interpretation in light of the claim language and the specification. The Court of Appeals for the Federal Circuit (CAFC) recently reversed the Board’s interpretation of a claim term in an IPR proceeding (IPR2015-00460) in which Samsung had challenged the validity of certain claims of U.S. Patent No. 6,146,997 of Home Semiconductor Corp. (“Home”) because it found that Board had adopted a claim construction “without regard to the context” in which the term was used in the claims and the specification. In a decision written by Judge Lourie last month, the Federal Circuit panel found that the PTAB had adopted an erroneous interpretation and reversed the decision stating that the PTAB’s finding of invalidity based by anticipation of claim 2 was “not supported by substantial evidence.” (See, Home Electronics v. Samsung Electronics, CAFC Decision No. 2016-2215, July 25, 2017).

The ’997 Patent concerned “a simplified method for forming a self-aligned contact hole,” in which a conductive plug can be formed to electrically connect the semiconductor device to other circuit elements. Independent claim 1 of the ‘997 Patent recites a method of forming a self-aligned contact hole in a semiconductor substrate having a gate electrode and a diffusion region by

forming a conformal layer of etch barrier material overlying the substrate surface including the diffusion region and the upper surface and the sidewalls of the gate electrode,

forming an insulating layer overlying the barrier layer, etching an opening through the insulating layer self-aligned and borderless to the diffusion region by using the barrier layer as an etch stop, and

anisotropically etching the barrier layer underneath the opening, thereby exposing the diffusion region and simultaneously forming a spacer of the etch barrier material on the sidewall of the gate electrode.

Claim 2 of the ‘997 Patent, which depends on claim 1, further recites “forming an oxide layer over the diffusion region and on the sidewalls of the gate electrode by thermal oxidation prior to forming the barrier layer.”

The construction of the phrase “forming an oxide layer over the diffusion region” was at issue in this proceeding. The Patent Owner, Home, argued that this phrase should mean “forming an oxide layer covering the diffusion region,” while the Petitioner, Samsung, argued that the broadest reasonable construction of this phrase is “forming an oxide layer above the diffusion region.” Samsung argued that construing “over” as “covering” was too narrow a reading for a person of ordinary skill in the art. The Board adopted Samsung’s proposed construction for this term and hence held that claims 2 and 9-14 of the ‘997 Patent were anticipated by U.S. Patent No. 6,277,720 (“Doshi”).

The CAFC held that the Board’s construction of “over” as meaning “above” is unreasonable in light of the claim language and the specification. The CAFC noted that “[i]n adopting the ‘full breadth’ of the term as advocated by Samsung, the Board focused on the word ‘above,’ rather than the claim term ‘over.’ That was error.” The CAFC further emphasized that “[e]ven when giving the claim term the broadest reasonable interpretation, the Board cannot construe the claims ‘so broadly that its constructions are unreasonable under general claim construction principles.’”

The CAFC reasoned that the language at issue “is not simply ‘over,’ but is ‘forming an oxide layer over the diffusion region,” and the use of the term ‘over’ in ‘forming an oxide layer over the diffusion region’ connotes more than an insignificant or incidental vertical overlap between the oxide layer and the diffusion region. Although ‘over’ and ‘above’ can be interchangeable in certain contexts, they are not coextensive here, and the full scope of ‘above,’ which is not a claim term, cannot be adopted to give meaning to the actual claim term ‘over’ if that adoption would result in an unreasonable interpretation of the claim term in the context.”
Continue Reading CAFC Finds Another PTAB Claim Construction Unreasonable and Again Reverses an Invalidity Holding

In a decision last month, the Court of Appeals for the Federal Circuit gave petitioners in AIA proceedings yet another weapon to invalidate patents – by affirming a Patent Trial and Appeal Board (PTAB) decision that relied, at least in part, on new evidence introduced by the petitioner in its reply brief. (Genzyme Therapeutic Products LP v. BioMarin Pharmaceutical Inc., Fed. Cir. No. 15-1720).

Writing for a three-judge Fed. Cir. panel, Judge William C. Bryson said it should be expected that petitioners will introduce new evidence during the course of an Inter Partes Review (IPR) proceeding. Judge Bryson dismissed the notion that the record of an IPR is essentially closed following the PTAB’s institution decision.

“There is no requirement either in the board’s regulations, in the [Administrative Procedures Act] or as a matter of due process for the institution decision to anticipate and set forth every legal or factual issue that might arise in the course of the trial,” according to Judge Bryson.

Genzyme had argued that it was impermissible for the PTAB to relied on different evidence than the evidence relied upon in the institution decision.

“Genzyme’s argument that the institution decision must refer to every bit of evidence that is relied on by the board in its final written decision reflects a misunderstanding of the role of the institution decision in inter partes review proceedings before the board,” said the judge.

The opinion draws a distinction between new grounds for invalidity and new evidence that supports the grounds on which the trial was initiated.   According to Judge Bryson, if the PTAB decision is based on the same grounds, due process is satisfied as long as the opposing party is notified and given a chance to respond.
Continue Reading PTAB Can Rely on New Evidence Introduced by Petitioner in its Reply

In Covidien LP v. University of Florida Research Foundation Inc., the Patent Trial and Appeal Board (the “Board”) upheld a defense of sovereign immunity asserted by the University of Florida Research Foundation (the “Foundation”) and dismissed three Petitions for Inter Partes Review (“IPR”) filed by Covidien LP (“Covidien”) against a patent owned by the Foundation. (See IPR2016-01274, IPR2016-01275, IPR2016-01276) The Board relied on the Supreme Court’s decision in Fed. Mar. Comm’n v. South Carolina State Ports Auth., 535 U.S. 743 (2002) (“FMC”) in its determination that the sovereign immunity defense applies to IPR proceedings, and it concluded that the Foundation was eligible to assert the defense as an “arm of the State” under Manders v. Lee, 338 F.3d 1304, *1309 (11th Cir. 2003) (en banc).

The Eleventh Amendment provides that the “judicial power of the United States shall not be construed to extend to any suit in law or equity, commenced or prosecuted against one of the United States by Citizens of another state, or by citizens or subjects for any foreign State.” The Supreme Court has interpreted the Eleventh Amendment as a grant of immunity to the States against certain adjudicative proceedings brought against them by private parties. In FMC, the Supreme Court held that the sovereign immunity defense applied to administrative adjudications before the Federal Maritime Commission, grounding its determination in the similarities between the Commission’s proceedings and civil litigation. The Board relied on the Supreme Court’s analysis in FMC in determining whether the sovereign immunity defense could similarly be implicated in IPR proceedings.

Covidien filed IPRs against the Foundation as a counter-action to a breach of license suit brought by the Foundation against it. The Foundation argued that the IPRs should be dismissed, asserting that it was an arm of the State of Florida, and as such entitled to sovereign immunity under the Eleventh Amendment. The Board’s decision was limited to the Foundation’s sovereign immunity defense. This decision appears to be the first extension of the sovereign immunity defense to an IPR proceeding.

Covidien argued that under FMC the sovereign immunity defense should not apply to IPR proceedings, distinguishing IPRs from civil litigation. Most notably, Covidien argued that IPRs are adjudications directed against the validity of a patent itself, unlike civil litigation which resolves disputes between two parties. Thus, Covidien argued, the subject of the IPRs were the Foundation’s patents, not the Foundation itself, and therefore the IPRs were not proceedings brought against the State. Covidien also warned that implicating the sovereign immunity defense in IPR proceedings would effectively insulate invalid patents from scrutiny just because they were owned by a State, an outcome that would thwart the purpose of creating IPRs. In addition, Covidien noted that if the Foundation’s defense was upheld, a private party could never counter a State’s infringement action by petitioning for IPR proceedings, giving States a stronger position in district court actions.

Relying on FMC, the Board rejected Covidien’s distinctions between IPRs and civil litigation. The Board noted that IPRs are adversarial proceedings between two parties decided by an impartial adjudicator, the Board. The Board also likened the discovery rules and procedures of IPRs with those in civil litigation, and noted that final decisions by the Board created issue estoppel. Additionally, the Board noted that the Federal Circuit had previously held that interference proceedings can be characterized as a lawsuit when determining whether sovereign immunity can be applied in Vas-Cath, Inc. v. Curators of University of Missouri, 473 F.3d 1376 (Fed. Cir. 2007). Thus, the Board held that the similarities between civil litigation and IPR proceedings were sufficient to implicate the sovereign immunity defense in IPR actions under FMC.


Continue Reading State Universities Rejoice: PTAB Recognizes Sovereign Immunity Defense

If Kyle Bass’s Coalition for Affordable Drugs Series II hedge fund was hoping to reap a windfall from short positions in Shire Plc’s stock this week, it was dealt a major setback by a Patent Trial and Appeal Board (PTAB) decision to uphold Shire’s patent on its colitis drug, Lialda®.  In a final written decision

The USPTO has gone ahead and finalized new rules for post-grant proceedings under the America Invents Act (AIA) – despite heavy criticism that the rules do little to alter the lopsided nature of these proceedings. The new rules were published at 81 FR 18750 on April 1, 2016 and go into effect on May 2, 2016.

Technically this “final rulemaking” amends various portions of 37 C.F.R. 42, the rules that govern post-grant proceedings under the AIA, including inter partes review (IPR), covered business method review (CBM), and post-grant review (PGR).

Perhaps the most significant change is that under the new rules the patent owner will be able to submit testimonial evidence, such as an expert declaration, as part of a patent owner’s preliminary response to a patent challenge before the Patent Trial and Appeal Board (PTAB) decides to institute an IPR, CBM, or PGR trial. (Under the existing rules, the Patent Owner usually cannot present testimonial evidence until after the institution decision and the PTAB makes its decision to institute trial after hearing only one side of the story, e.g., from the petitioner’s expert.)

However, 37 CFR 42.108(c) has been revised such that if the patent owner presents testimonial evidence as part of a preliminary response, any “genuine issue of material fact created by such testimonial evidence will be viewed in the light most favorable to the petitioner solely for purposes of deciding whether to institute an inter partes review.” An analogous new rule in 37 CFR 42.208(c) for a post grant review has also been finalized. Under the new rules petitioners may also seek leave to file a reply to any preliminary response filed by the patent owner.

These changes beg the questions: what do the patent owners have left to say after institution if their experts’ opinions have already been considered and found unpersuasive, and will the PTAB judges ever change their minds during trials when the petitioner’s evidence is not viewed in its most favorable light?
Continue Reading New Final Rules for Post-Grant Proceedings Published by USPTO on April Fools Day

It’s time for an update on Kyle Bass’s efforts to rid America of the pharmaceutical patents that support high priced drugs.  Between February and September 2015, at least eleven investment funds organized by J. Kyle Bass and Erich Spangenberg (the Coalitions for Affordable Drugs Series I – XI) filed nearly three dozen different petitions for review of patents held by various drug companies.  The petitions were designed to take advantage of the new inter partes review (IPR) proceedings established under the America Invents Act (AIA) in 2012.

Speculation has been rampant as to how Bass’s investors will benefit.   Most people think that the funds have been shorting (or will short) the shares of the publicly traded pharmaceutical companies that own the patents; wait for the stock values to tumble and then cover their short positions by buying the stocks at a hefty discount caused by their patent challenges.  Others suggest that the funds will invest in generic drug manufacturers that will be able to compete once the drug patents are eliminated.

In the fall of 2015, Bass and Spangenberg appear to have switched gears and began filing petitions in their own names rather than in the names of the various Coalitions for Affordable Drugs (CAD) funds.  Whether this represents an actual change in the funding of the IPR challenges or just a legal nicety (i.e. a conclusion that the underlying CADs need not be named under USPTO rules) is not clear.

The hopes of the pharmaceutical industry that these petitions would be quickly dismissed out of hand have been dashed by the Patent Office.  Despite initial setbacks for the CADs early last year, over half of the petitions (18 out of 33) have now been found to present a reasonable likelihood of success.  In each of these instances, a trial is underway to determine whether the patent is invalid.  Given the high statistical likelihood (over ninety percent) that patents challenged under the AIA are ultimately found at least partially invalid once a trial is completed, the pharmaceutical companies have reason to be worried.
Continue Reading Bass Continues Fishing; Pharma Seeks Sanctuary

In a rare case of disagreeing with the Patent Trial and Appeal Board (PTAB), the Court of Appeals for the Federal Circuit (CAFC) vacated and remanded a PTAB decision invalidating claims 10-25 of PPC Broadband, Inc.’s U.S. Patent No. 8,323,060, which were challenged in an inter partes review (IPR) proceeding by Corning Optical Communications RF, LLC. (IPR2013-00342).

The challenged claims of PPC’s patent relate to a coaxial cable connector and require that the cable connector include “a continuity member having a nut contact portion positioned to electrically contact the nut and positioned to reside around an external portion of the connector body when the connector is assembled …” The Board held that the broadest reasonable construction of “reside around” was “in the immediate vicinity of; near.” Based on this construction, the Board concluded that the claims were obvious in view of the references cited by the petitioner, Corning, against the claims.

The Board reached this construction by relying on the broadest dictionary definition of the term “around.” In contrast, PPC (the patent owner) had proposed that the broadest reasonable construction of the term “reside around” in light of the claims and the specification is “encircle or surround.”

The CAFC sided with the patent owner and held that in the context of the patent the Board’s construction was not reasonable. The CAFC explained that “[t]he fact that ‘around’ has multiple dictionary meanings does not mean that all of these meanings are reasonable interpretations in light of the specification.” The CAFC further stated that all of the claims of the patent are directed to coaxial cable connectors and the components of these connectors partially or wholly encircle the inner electrical conductor. The CAFC emphasized that “[g]iven the context of this technology, it seems odd to construe the term ‘reside around’ without recognizing the context of its use in terms of the coaxial cable at issue.”
Continue Reading CAFC Vacates a PTAB Decision Due To Faulty Claim Construction